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Echosens

FDA 510(k) & PMA Approved Devices — 8 products

Total Devices8
Categories1
Latest Approval2023-03-02
TypeNumberDevice NameCodeDate
510(k) K223902 FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630) IYO 2023-03-02 View
510(k) K212035 FibroScan 230 IYO 2021-07-30 View
510(k) K203273 FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630) IYO 2021-03-25 View
510(k) K200655 FibroScan® 630 IYO 2020-07-16 View
510(k) K181547 FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) IYO 2018-07-09 View
510(k) K173034 FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) IYO 2017-11-14 View
510(k) K172142 FibroScan 430 Mini+ IYO 2017-09-13 View
510(k) K160524 FibroScan 530 Compact IYO 2016-03-18 View
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